|- candidate number||28780|
|- NTR Number||NTR7134|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-apr-2018|
|- Secondary IDs||2017-3510 Filenumber CMO Radboudumc|
|- Public Title||Gight Pilot Study|
|- Scientific Title||Pilot Study on Falls Prevention with GIGHT, The Guiding Light.|
|- Healt Condition(s) or Problem(s) studied||Falling, Risc|
|- Inclusion criteria||- Participant is at least 65 years of age |
- Participant is able to get up from bed and walk to the bathroom independently
- Participant is able to collaborate in outcome registration by themselves or assisted by a caregiver and/or partner
- Participant gives informed consent for participating in the study
|- Exclusion criteria||Presence of cognitive, hearing or vision impairments which make it impossible to take part in the pilot study as judged by the BrabantZorg professionals and the caregivers|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||5-okt-2017|
|- planned closingdate||1-jun-2018|
|- Target number of participants||150|
|- Interventions||Gight™ (The guiding light) is an innovative lighting device, consisting of series of low voltage (12V) LED’s, which are connected in linear strips that can be placed at the floor, connected to the side walls to guide persons from their bed to the door or bathroom. The LED strip is connected to the electricity net by a socket transformer and is activated by a motion sensor at low light intensity. Gight is CE approved. The Gight device will be installed in participant’s bedroom or hallway en route to the bathroom. |
|- Primary outcome||Fear of falling when leaving the bed in darkness on a scale from 0-10. This item is adapted from the well validated FES-I (Falls Efficacy Scale), which has no item on fear of falling over night. Difference post-intervention (at 1-6 months after start) and baseline is the primary outcome.|
|- Secondary outcome||1. Fall rate |
(as reported by participants on a falls calendar)
2. Sleep quality over the last month on a scale form 0-10
(measured with an item from the well validated Pittsburgh Sleep Quality Inventory (PSQI))
3. Gight acceptability and subjective fear of falling and sleep quality (as reported in a semi-structured interview about the experience of Gight usage)
Difference post-intervention (at 1-6 months after start) and baseline are also taken for secondary outcomes.
|- Timepoints||Outcomes will be registered every 4 weeks. |
1. At baseline, FES-I (including adapted question regarding falling at night), PSQI and self-reported fall history (6 months) will be registered. TOPICS-MDS will be used to determine descriptive variables
2. At follow-up visits, self-reported fall frequency and one item of each FES-I and PSQI will be registered. Every second visit TOPICS-MDS will be repeated
3. At last visit, baseline measurements will be repeated, including a semi-structured interview on the acceptability of Gight
|- Trial web site||http://www.gight.nl/project/proef-bij-brabantzorg-in-de-gemeente-oss |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||BSc Thessa Thölking|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Marcel Olde Rikkert|
|- Sponsor/Initiator ||BrabantZorg Oss, Gight-BV|
(Source(s) of Monetary or Material Support)
|BrabantZorg Oss, Municipality of Oss|
|- Brief summary||Rationale: Falling is a major health problem in older subjects, for which insufficient lighting at night is a relevant risk factor. So far, no interventions have been directed at improving lighting by guiding persons going out of bed with automated LED lights for older subjects. |
Objective: To examine the acceptability and effectiveness of using the Gight lighting on reducing fear of falls, fall frequency and improving sleep quality in older subjects being served by BrabantZorg, a large home care organisation in the Oss region.
Study design: Pragmatic design modelled after a stepped wedge design with inclusion rate of 25 subjects every month for six months, but which will be tailored in practice to the feasibility of inclusion met in practice in the care practice of BrabantZorg.
Study population: 150 community dwelling clients of BrabantZorg, aged 65 and above.
Intervention: Gight™ automated LED guiding light is installed at home.
Main study parameters/endpoints: Effectiveness is measured by self-registered fall frequency, and standardized questions on fear of falling, and sleep quality. Descriptive variables will be acquired using the TOPICS- MDS minimum dataset. Qualitative data on acceptability of Gight will be acquired by a short semi-structured interview at the end of the intervention period, which will be anonymised and audiorecorded.
|- Main changes (audit trail)|
|- RECORD||7-apr-2018 - 15-apr-2018|